Health Care Partner Hillary Stemple will give a presentation titled “Examining the Current Administration’s Stand on ACA and Pharmacy Costs and What This Means for the Industry” at Q1 Productions’ 17th Annual Managed Markets & Account Management Strategies Conference on October 15, 2026.
The wellness and longevity industry is booming, and many brands are branching into supplements. The US Food and Drug Administration (FDA) and consumer class action lawyers judge your product the same way: What does it promise, and can you back that up? A lawsuit can arrive before the FDA ever does.
On September 18, the US Food and Drug Administration (FDA) issued a warning letter to Empower Pharmacy, a Houston-based compounding pharmacy that was producing GLP-1 weight-loss drugs (semaglutide and tirzepatide) at high volume.
In July 2025, the US Food and Drug Administration (FDA) issued a Warning Letter asserting that Whoop’s blood pressure estimation feature was a medical device requiring premarket clearance. In June 2026, the FDA issued a closeout letter resolving the matter.
Pat Naples was quoted discussing the Centers for Medicare & Medicaid Services’ (CMS) planned launch of the Independent Dispute Resolution (IDR) Gateway, a new online platform intended to improve transparency and efficiency in the No Surprises Act (NSA) arbitration process.
“Whether ‘tis nobler to deviate from the RLD and rely on established data, or take arms against a sea of troubles with a bioequivalent product that conforms to the sameness requirement — that is the question.” That might have been Shakespeare’s opening to Hamlet, had the Bard traded quills for regulatory submissions and Denmark for the District of Delaware or New Jersey.
Health care providers using skin substitutes now face a two-front enforcement campaign. On August 5, the US Attorney’s Office for the District of Nevada indicted physician Dr. Stephen Dubin on health care fraud charges, alleging a $95 million illegal kickback scheme to bill Medicare for medically unnecessary amniotic wound allografts.
The Texas Attorney General’s office recently announced a settlement of nearly $34 million with AstraZeneca Pharmaceuticals LP. The settlement resolves allegations that AstraZeneca violated the Texas Health Care Program Fraud Prevention Act (THFPA) — the state-law analog to the federal False Claims Act and Anti-Kickback Statute (AKS) — in connection with the sale of 17 of the company’s drugs.
In Sala v. Premier Imaging Holdings, LLC, 240 Conn. App. 793, 2026 WL 2220267 (Conn. App. Aug. 4, 2026), the Connecticut Appellate Court affirmed the trial court’s decision to overturn an arbitration award that had declared a physician noncompete “valid and binding,” because the arbitration award enforced a restrictive covenant that exceeded the one-year and 15-mile limits for physician noncompetes allowed under CT Gen Stat § 20-14p.
ArentFox Schiff is pleased to announce that 125 attorneys have been recognized by The Best Lawyers in America 2027, with two attorneys highlighted as “Lawyers of the Year” and 36 attorneys listed as “Ones to Watch.”
On August 11, out-of-network health care providers scored an important, although not complete, victory under the federal No Surprises Act (NSA) when the US Court of Appeals for the Fifth Circuit, sitting en banc, issued its decision in Texas Medical Association v. United States Department of Health and Human Services, No. 23-40605.
Health Care Practice Co-Leader Douglas Grimm was quoted on how the publicly traded health system Q2 financial reports are a barometer of the state of the current marketplace, as well as a sign of what is coming.
Health Care Practice Co-Leader Douglas Grimm was a featured guest on Competition Policy International, a PYMNTS company, to discuss how deregulating artificial intelligence (AI) for use in health care doesn’t necessarily remove barriers to the industry’s adoption.